Trs 996 annex 6
WebUntitled - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Web(2) Qualifying distributions Any actual distribution made pursuant to section 992(c) (relating to distributions to meet qualification requirements), and any deemed distribution pursuant …
Trs 996 annex 6
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Web6. New applications 354 7. Considerations for changes in product information and labelling 354 8. Procedures 355 8.1 General 355 8.2 Presubmission meetings 355 8.3 Proposed documentation for minor variations 355 8.4 Proposed documentation for variations requiring prior approval 356 8.5 Review procedures 357 References 357 Annex 10 Web6. AUDIT TRAIL. 6.1. Chromatographic systems should have an audit trail(s) which reflects, for example, users, dates, times, original data and results, changes and reasons for …
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WebDec 14, 2024 · Figure 15.B-6 Definition of true copy excerpted from the glossary of the WHO Guidance on good data and record management practices (TRS No. 996, Annex 5, 2016) Data type: Paper data: Electronic data types: Original data: Initial capture of a document, data entry, or first printout. Primary data or original data is the first or originally ... WebAppendix 3, Part A of WHO TRS 996 Annex 8, Expression of interest to the national regulatory authorities (NRAs) in the assessment and accelerated national registration of a World Health Organization (WHO)-prequalified pharmaceutical product or vaccine (Annex B). In cases where the applicant company is not the original WHO PQ holder, the ...
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WebWilson Ave . . . Wilson Ave. Clayson Rd: Jane St: Julian Rd East Side - Humber River Hospital: Keele St: Dubray Ave chotuki mastichotu satta kingWebthe WHO GMP requirements (WHO TRS 996, Annex 3 2016; TRS 961, Annexes 2, 3 and 6). WHO has conducted independent testing of batches of the SKYVaricella Inj. Vaccine for critical release parameters in contracted laboratories qualified by WHO for the purpose, results obtained were in and chotu ki committeeWebAnnex 5 167 1. Introduction 1.1 Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, … chotu taj satta king 2021Web6.1. Chromatographic systems should have an audit trail(s) which reflects, for example, users, dates, times, original data and results, changes and reasons for change. (See also WHO Guidance on good data and record management practices, TRS 996, Annex 5, 2016.) 6.2. Full audit trails should be enabled from the time of installation of software. 6.3. chotto matte meaning japaneseWebJul 31, 2015 · Sterilization by gases and fumigants 6.14 Sterilization by gases and fumigants should only be used for finished products where there is no suitable alternative. 16. 276 6.15 Various gases and fumigants may be used for sterilization (e.g. ethylene oxide and hydrogen peroxide vapour). Ethylene oxide should be used only when no other method is ... chotu taj satta king onlineWebOct 10, 2016 · TRS 996 - Annex 6: WHO good trade and distribution practices for pharmaceutical starting materials. Annex 6, WHO Technical Report Series, No. 996. 10 … chotu taj satta king